Apparatus and methods for tissue closure

ABSTRACT

Apparatus and methods are provided for treating a tissue opening, for example a trocar opening used in a minimally invasive surgical procedure. In a tissue closure device, a finger guard or shield can be used, handle or holding area or areas can be used, and positioning indicators can be used. A resiliently flexible target material can also be used for reliably holding a suture during the procedure. Introducers can be used having a suture holder, an alignment indicator and insertion limits.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.15/583,879 (filed May 1, 2017, now U.S. Pat. No. 10,485,533), which is acontinuation of U.S. patent application Ser. No. 14/589,647 (filed Jan.5, 2015, now U.S. Pat. No. 9,636,105), which is a continuation of U.S.patent application Ser. No. 13/144,291 (filed Oct. 3, 2011, now U.S.Pat. No. 8,926,639), which is the national stage of InternationalApplication No. PCT/US2010/020652 (filed Jan. 11, 2010), which claimsthe benefit of U.S. Provisional Patent Application No. 61/144,151 (filedJan. 12, 2009), the disclosures of which are hereby incorporated byreference as if set forth in their entireties herein.

BACKGROUND i. Field

This relates to tissue closure devices, including surgical suturingdevices as well as such devices that can be used for intra-abdominalsuturing and suturing of puncture wounds generated by surgical trocarsand other puncturing devices.

ii. Related Art

Minimally invasive methods for conducting surgery on internal organs,tissues, ligaments and bones use extremely small instruments such ascatheters, laparoscopes, and the like. The instruments are introducedusing very small incisions, for example on the order of five to 18 mm indiameter, into which a trocar or other introducing device is placed. Thetrocars may have a diameter, for example, between 3 mm and 30 mm, withthe smaller trocars leaving the opening substantially unchanged. Thelarger trocars may enlarge the opening. The trocars provide a reliableand fixed opening for introducing and removing various surgicalinstruments, viewing devices and other instruments used during thesurgical procedure.

While the incisions and the trocar opening are quite small bytraditional surgical standards, they still require closure aftercompleting the surgical procedure. Surgical closure reduces thepossibility of post-surgical infection, post-surgical herniation (forexample in abdominal surgeries), subsequent bleeding or other effects.Closure can be accomplished either through manual suturing or suturinginstruments used to complete the closure. In either case, suturing ismade difficult by the small opening size, for example not only formanipulating the suture but also for visualizing the procedure. Closureis also made more difficult by the need to suture the subcutaneoustissue, for example fascial layers, separate from closure of theoverlying skin, and doing so through a very small opening in the skin.

Conventional closure techniques such as those for closing openings inthe abdominal wall pass sutures through the abdominal wall tissue adistance from the original trocar incision. One or more sutures are thentied off to close the subcutaneous layer followed by suitable closure ofthe skin layer. It has been noted that the distance of the suturelocation from the original incision opening is important in order tosecure a suitable amount of abdominal wall tissue for forming a reliableclosure. If the distance is too small, the closure may not be enough toreliably close the opening without later complications. See, forexample, US Patent Publication 20060030868, incorporated herein byreference.

Tissue closure devices, for example laparoscopic port closure devices,may be introduced into the opening after removal of the trocar device tomake easier the suturing of the trocar opening. Various methods andstructures may help in closing the opening, but may require asignificant number of steps for completing the closure, Some devices mayrequire a significant amount of manual care in suturing the opening andtying off the suture, as well as close visualization for accomplishingthe closure. Additionally, some devices have a significant number ofcomponents or special devices in order to accomplish the closure, orthey may not provide consistent and reliable results even under normaloperating circumstances.

SUMMARY

Apparatus and methods are provided that are easy to use for closing atissue opening, for example a trocar opening used in a minimallyinvasive surgical procedure. One or more of the examples of theapparatus and methods described are easy to use and provide a reducednumber of steps to produce a consistent and reliable closure. Theapparatus and methods may be more simple than conventional techniques,and can be possibly done without scope visualization under appropriatecircumstances. One or more of these features can be provided with theapparatus and methods described herein. In one example of apparatus andmethods for closing a tissue opening, for example an abdominal trocaropening used in surgery, a closure device is used for closing the tissueopening. A passageway in the closure device, which in one example may bea trans-lateral passageway, is used to guide a needle or other suturecarrier along the passageway and through a tissue layer to be closed. Asurface or barrier formed on the closure device distal of an opening tothe passageway helps to protect an operator's finger while a suture isbeing introduced to the passageway in the body. The surface or barriermay be a shield, disc, plate guard or other blocking element that canreduce the possibility of needle stick when an operator's finger orfingers are placed under the surface and the introducer is introducedinto the opening from the proximal side of the surface. Where theclosure device has a single suture introducing opening, the surface cansurround the opening with sufficient coverage over the operator'sfingers without fully encircling the closure device. Where the closuredevice has two or more suture-introducing openings, respective surfacescan surround the openings, or a single surface can surround all openingsand extend completely around the body. In an example where the closuredevice has an even number of suture-introducing openings, the openingsmay be arranged in pairs, for example on diametrically opposite sides ofthe body. For such openings, the surface can conveniently extendcompletely around the body.

In one example of a closure device having a needle-introducing opening,the body of the device may include finger grasping areas foraccommodating an operator's fingers. The grasping areas may includesurfaces complementary to finger curvature, and may include surfacevariations for helping the operator to grasp the body of the closuredevice. The surface variations may be ridges, grooves, knurling,dimples, surface texture variations or other surface variations to helpthe operator reliably grasp the body of the closure device. In anotherexample of apparatus and methods for closing a tissue opening, forexample a trocar opening, a closure device with a passageway forreceiving a suture-carrying needle or other closure device includes asurface or other construction adjacent the opening for shielding anoperator's fingers from needle sticks. The closure device may alsoinclude a slot or other longitudinally extending opening extending froma surface of the body to the passageway. The slot allows the suture tobe disengaged from the body of the closure device after the needle orother closure device has carried the suture along the passageway andthrough a tissue layer. The suture can be disengaged from the passagewaywhile the closure device is still positioned in the trocar opening orduring or after the closure device is removed from the trocar opening.In a closure device having a shield for an operator's fingers, the slotmay also extend into the shield, thereby permitting separation of thesuture from the passageway over the entire length of the passageway. Inone example, the slot extends longitudinally of the closure device body,and may also extend partially about a perimeter of the body. Where theclosure device includes a plurality of suture-introducing passageways, arespective number of slots, each corresponding to a passageway, permitseparation of the suture from the closure device completely from abovethe shield to below the shield. In a further example of a closure devicefor closing a tissue opening, for example a trocar opening, the closuredevice includes a longitudinally extending body having a proximalportion and a distal portion. The distal portion of the closure devicebody includes one or more projections extending at least partlylaterally of the body and having a suture-receiving target material. Thetarget material is resiliently flexible and initially has anun-perforated proximal surface. The target surface is also configured tobe capable of being punctured by a needle or other device suitable forcarrying a suture multiple times in a given patient in a surgicalsetting. In one example, the target surface material is selected so asto reliably hold a length of suture using friction between the outerwall of the suture material and target surface material, for example asize 0 suture, under normal operating conditions. A suitable targetsurface material includes silicone rubber, but may include but be notlimited to other commonly available biocompatible thermoset orthermoplastic materials (e.g. Polyurethane, polyethylene, C-flex, andthe like) that may consist of a single or compounded materials, suitableto provide the desired friction force to hold and retain the commonlyused surgical suture materials. The target material may consist of asingle layer material or may be of several layers, each layer havingdifferent characteristics or properties designed to achieve the frictionnecessary to hold the suture in place but at the same time flexibleenough to allow any needle or other suture carrying device to penetrate.With the described configuration, specially-configured target materialsare not required.

In an additional example of a closure device for closing a tissueopening, for example a trocar opening, the device includes alongitudinally extending body. The body includes a proximal portion anda distal portion, the proximal portion being used for manipulating theclosure device and the distal portion for extending within the trocaropening and for making easier the placement and retrieval of one or moresutures. The body further includes one or more indicators or markingsfor visibly indicating proper location or positioning of the closuredevice for optimal operation. For example, a visible marking can be usedto indicate maximum tissue depth, or maximum depth of the closure deviceinto the tissue. In another example, or in addition, a visible markingcan be used as visual warning to the operator that the patient's softtissue bed may be too insubstantial in terms of thickness and, if theindicator is at or near the skin layer upper surface, that the needlewill exit at a point above the skin level instead of below it asdesired. In another example, or in addition to one or more of the othermarkers, a visible marking can be used to indicate desired closuredevice positioning within a trocar opening relative to a tissue layer tobegin or transition the closure device to another configuration. Forexample, the tissue layer may be the peritoneum, and the visible markingmay be used to indicate that a target element for a suture is positionedfor deployment. In another example, the visible marking may be used as avisual warning to the operator that the patient's soft tissue bed may betoo insubstantial in terms of thickness and, if the indicator is at ornear the skin layer upper surface, that the needle will exit at a pointabove the skin level instead of below it as desired. In a furtherexample, a visible marking may be used to indicate when the closuredevice has been positioned within the tissue opening, for examplerelative to a peritoneum layer, to permit the easiest retrieval of asuture that may be held at that time on a part of the closure device.

In a further example of a closure device for closing a tissue opening,for example a trocar opening, the device includes a longitudinallyextending body having a proximal portion and a distal portion. Thedistal portion includes a suture holding portion extending a firstdistance laterally from a first axial position on the body. The bodyfurther includes a substantially straight, suture-receiving passagewayextending at an angle to a central axis of a body. The passagewayincludes an entrance opening and an exit opening on the body distal ofthe entrance opening and it is substantially aligned with the sutureholding portion. The exit opening on the body is positioned proximallyat a second axial position relative to the first axial position andspaced therefrom a second distance. The angle of the passageway, thesecond distance and the first distance are chosen so that a ratio of thesecond distance to the first distance is no more than preferablyapproximately 2.5:1. For example, if the suture holding portion isspaced from the body approximately 1 cm, the distance from the firstaxial position on the body to the exit opening is no more thanapproximately 2.5 cm. The ratio can be less than 2.5:1, but in oneexample, the first distance between the first axial position on the bodyand the suture holding portion is at least 1 cm.

Additionally, if the first distance between the first axial position onthe body and the suture holding portion is at least 1 cm, the ratio canbe less than 2.5:1, for example by adjusting the second distance or byadjusting the angle of the passageway, or both. Examples of accessoriesand their use with closure devices for tissue openings, needles orsuture introducers can include one or more features for making heir useeasier with closure devices. One feature may include a combination ofneedle length and handle configured such that when the needle is fullyintroduced into the closure device, the handle or other structure on theneedle contacts a structure on the closure device substantiallypreventing further introduction of the needle into the closure device,and therefore substantially preventing further ingress of the needleinto a tissue layer. Such a configuration reduces the possibility ofunintended needle stick of a tissue layer, organ or other nearbysurface. Additionally, such a configuration in combination with anappropriately-designed closure device for known patient anatomies allowsan operator to more confidently follow the closure steps in less timeand with fewer redundant steps. Alternatively, a visual marking orposition indicia provided in the needle structure may also be used as ameans to indicate the depth of the needle during suture introduction.

In another feature for an accessory and its use, such as that for aneedle or suture introducer, the needle may include a distal point and asuture-retention structure proximal of the needle point. The retentionstructure may include a groove or undercut having an entrance openingwhere the entrance opening is sized larger than the suture and allowsloading of the suture into the groove or undercut. The groove orundercut is sized such that the narrowest opening includes a maximumspacing slightly less than the suture diameter to be used with theneedle. The maximum spacing is selected so as to reliably hold thesuture within the groove when the suture is in a relaxed configuration,and for example under the weight of gravity. However, for a greaterforce such as might be applied manually, the suture can be removed fromthe groove and out the opening. Such a greater force would be greaterthan the force of gravity on the suture hanging from the groove. In thepresent applications for a needle in use with a closure device, thegroove opens distally and has a groove bottom proximal of the opening.

A further feature for an accessory and its use, such as that for aneedle or suture introducer having a groove for releasably retaining asuture, the groove is formed in a side of the needle proximal of adistal needle tip. The needle includes an indicator on a side surface ofthe needle at a proximal portion of the needle, and the indicator ispositioned perimetrically with respect to the needle at about the sameposition as the groove is located. The indicator can be a raised,longitudinally-extending the ridge or land, an arrow, grooves, uniquefinger holdings or other configurations indicating the groove position.The operator can use the indicator to establish in which radialdirection the groove entrance opening is facing when the needle tip isnot easily visualized, such as when it has passed through or beyond atissue layer. This feature is also beneficial to the operator orsurgical team when manually loading the suture into the needle groove inan operating room or suite where the lighting has been dimmed or isabsent.

Accessories for use with closure devices for tissue openings canincorporate any one or more of the features described herein withrespect to a needle or suture introducer. The needle may also include ahandle having finger grip surfaces or other manual assist configurationsfor helping the operator manipulate the needle.

The apparatus described herein, as well as other apparatus, can be usedin accordance with one or more methods for closing tissue openings. Inthe context of using one or more methods with a closure device describedherein, such as may be used for closure of abdominal trocar openings,the closure device can be inserted into a trocar opening after thetrocar has been removed. In one example, the closure device can beinserted until the skin surface comes adjacent a proximal indicator, forexample a circumferential line about the closure body. Additionally,where scope-based visualization s available, clearance of a distalindicator interior to the peritoneum indicates that the target wings orother target elements can be deployed laterally of the closure body.Alternatively, where scope-based visualization is not used or available,the skin surface adjacent the proximal indicator will indicate that thetarget wings or other target elements can be deployed laterally for mostpatients. Sutures can then be introduced and closure effected asdesired. The apparatus described herein, as well as other apparatus, canbe used in accordance with another example of a method for closingtissue openings. Regardless of whether or not the foregoing method ofpositioning a closure device is used, sutures can be introduced intotissue layers through a closure device using a suture-carryingintroducer, for example a needle. The needle can be loaded with a suturemanually or automatically by moving a suture portion along the shaft ofa needle toward a groove opening at a distal portion of the needle. Thesuture portion is moved along the shaft proximal to distal or distal toproximal until the suture portion enters the groove opening, for exampleradially inward from the shaft outer surface, after which the sutureportion is moved proximally of the needle tip. The operator mayappreciate a tactile sensation when the suture enters the groove openingand also observe it visually depending upon the lighting in theoperating room. A slight force is applied to the suture portion toovercome a restriction in the groove opening having a dimension slightlyless than an outer dimension of the suture, after which the suturepasses the restriction and reaches the bottom of the groove, for exampleat the proximal-most portion of the groove. The retention of the sutureportion in the groove can be tested if desired by directing the needlepoint downward with the suture also extending downward by gravity. Thespacing of the restriction in the groove opening is such that the sutureremains within the groove as the force necessary to move the sutureportion past the groove restriction is greater than the force of gravityon the suture. The suture can then be introduced, as well as othersutures, into the tissue and closure effected as desired. In additionalexamples, apparatus such as that described herein as well as otherapparatus can be used in accordance with a further example of a methodfor closing tissue openings. Whether or not any other methods herein ofpositioning a closure device or loading a suture-carrying introducer areused, a closure device inserted into a trocar opening can be loaded withone or more sutures without requiring the operator to intervene tomanually or with additional tools detach a suture from an introducer andattach the suture to the closure device. In one example, the closuredevice is inserted into the trocar opening with a relatively highfriction target material on a distal portion of the closure device, forexample below the peritoneum. The target material is high frictionrelative to the suture material to be used with the closure device.Additionally in one example, the target material is un-perforated priorto initial use and presents a uniform, un-breached surface facingproximally for receiving the suture. The target material is alsoresiliently flexible, and when a suture introducer, for example asuture-carrying needle, breaches the proximal-facing surface and embedsthe suture in the target material, the friction generated in the targetmaterial grasps and holds the suture even as the introducer iswithdrawn. One exemplary introducer may have a reduced-opening groovefor loosely holding a suture portion that can be removed by withdrawingthe introducer from the target material. Other sutures may be introducedand closure effected as desired.

In another example of a method for closing a tissue opening, a closuredevice may be preloaded with one or more sutures and introduced into atissue opening, for example a trocar opening. When the closure device issuitably inserted, one or more respective wings or suture-holdingelements may be deployed substantially laterally of a closure devicebody. In one example, a suture is releasably positioned and held atleast 1 cm laterally away from the closure device body. In anotherexample, a suture may be held in a resiliently flexible material, forexample embedded in silicone rubber or other suitable bio-compatiblematerial that provides the desired friction properties in conjunctionwith the suture. The tissue layer overlying the suture is then piercedwith a retriever element, the suture retrieved and then pulled throughthe tissue layers to a position outside the patient. Similar steps canbe followed for retrieving any additional sutures, and then closurecompleted as desired. Other closure device configurations are alsopossible for use in this procedure, for example one in which one or moresutures are held by physical restrictions or interference fits betweenthe suture and the suture holder (for example on a wing or othersuture-holding element). Additionally, the closure device can include aguide channel or other retriever guide defining the path for theretriever necessary to substantially guarantee contact between thedistal tip of the retriever and the target suture, for example evenwithout visualization. Such a guide may be a channel, such as oneextending along a line intersecting the target suture position, or atrans-lateral channel extending from one side of the closure device bodyto the other side and then intersecting the target suture position. Aplurality of such guides may be included, for example for respectivesuture positions.

In a further example of a method for closing a tissue opening, a closuredevice, including any of those described herein, may be introduced intoa tissue opening, for example after removal of a trocar. If the closuredevice has been properly introduced into the opening, for example asindicated by a proximal indicator being adjacent a skin surface or asindicated by visualization of a distal indicator being inferior to thetissue layer to be closed (for example a peritoneum and abdominalfascia), one or more wings or other suture target elements can bedeployed laterally of the closure device body. The target or targetelements may be deployed preferably at least 1 cm from the closuredevice body (measured perpendicular to the body). They are deployed bymanipulating an actuator rod relative to the closure device body, suchas through manipulator rings or other grasping elements. In one example,the target elements may be locked in an insertion position (un-deployed)until unlocked. Once deployed, the target elements can also be locked inthe deployed configuration, for example through re-engagement of alocking element. When the closure device is positioned and configured asdesired, the operator can grasp the body of the closure device at a bodyposition distal of suture openings. While grasping the body, a suturecarrying introducer is inserted into an opening and guided throughtissue to be closed and into a respective target element. In oneexample, the guide is a trans-lateral passageway with an entranceopening above the operator's grasp on the closure device body and anexit along a line substantially intersecting the suture target. Aclosure device may be used that has a guard or shield between theoperator's grasp on the closure device body and the suture openings.

In the method described in the foregoing paragraph, the suture may beintroduced using an introducer with a stop or other element on theintroducer that engages a corresponding surface on the closure devicethat prevents further ingress of the introducer through the tissue andthrough the target. The introducer may include grasping surfaces and/oralignment indicators for assisting the operator in properly positioningthe suture in the target element. The introducer can be removed leavingthe suture in the target element, for example embedded in a relativelyhigh friction, resiliently flexible material, for example siliconerubber, and other sutures introduced in a similar manner, if desired.When the desired number of sutures have been embedded in theirrespective targets, a lock or latch is released and the suture targetsreturned to their insertion configuration using the manipulator rings orother grasping elements. The closure device can then be withdrawn fromthe tissue opening carrying with it the suture or sutures previouslypassed through the desired tissue layer. The tissue layers may then beclosed by securing the sutures, and the overlying skin layer may also beclosed. In all methods and devices described herein, it is understoodthat the devices and steps taken to achieve the desired result can berepeated for subsequent closures on the same patient as required.

These and other examples are set forth more fully below in conjunctionwith drawings, a brief description of which follows.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an upper left front isometric view of a tissue closure deviceaccording to one example and a suture introducer according to oneexample inserted into a guide of the closure device.

FIG. 2 is a left side elevation view of the assembly shown in FIG. 1including a partial schematic of a tissue layer into an opening in whichthe closure device may be inserted.

FIG. 3 is a right side elevation view of the assembly of FIG. 1 .

FIG. 4 is a lower right rear isometric view of the assembly of FIG. 1 .

FIG. 5 is a bottom plan view of the assembly of FIG. 1 .

FIG. 6 is a front elevation view of the closure device of FIG. 1 .

FIG. 7 is a left side elevation view of the closure device of FIG. 1 .

FIG. 8 is a bottom plan view of the closure device of FIG. 1 .

FIG. 9 is a top plan view of the closure device of FIG. 1 .

FIG. 10 is a longitudinal cross-section view of the closure device takenalong 10-10 of FIG. 9 .

FIG. 11 is a longitudinal cross-sectional view of the closure devicetaken along line 11-11 of FIG. 9 .

FIG. 12 is a left side elevation of the closure device of FIG. 1 in aninsertion configuration.

FIG. 13 is an upper isometric view of a slide unit having finger ringsfor changing the configuration of the closure device of FIG. 1 .

FIG. 14 is a top plan view of the slide unit of FIG. 13 .

FIG. 15 is a front elevation view of the body of the closure device ofFIG. 1 ,

FIG. 16 is a side elevation view of the body of the closure device ofFIG. 1 .

FIG. 17 is a top plan view of the body of the closure device of FIG. 1 .

FIG. 18 is a bottom plan view of the closure device of FIG. 1 .

FIGS. 19-23 are transverse cross-sectional views of the closure devicebody taken along the respective lines in FIG. 16 .

FIG. 24 is an upper isometric view of a suture target wing for theclosure device of FIG. 1 .

FIG. 25 is a bottom plan view of the suture target wing of FIG. 24 .

FIG. 26 is a side elevation view of the suture target wing of FIG. 24 .

FIG. 27 is a rear elevation view of a suture target wing of FIG. 24 .

FIG. 27A is a longitudinal cross section of the target wing of FIG. 27taken along line 27A-27A.

FIG. 28 is a lower front isometric view of the suture target wing ofFIG. 24 .

FIG. 29 is a front isometric view of a needle assembly from the assemblyof FIG. 1 .

FIG. 30 is a front plan view of the needle assembly of FIG. 29 .

FIG. 31 is a detailed view of the tip of the needle assembly of FIG. 29taken at 31-31.

DETAILED DESCRIPTION

This specification taken in conjunction with the drawings sets forthexamples of apparatus and methods incorporating one or more aspects ofthe present inventions in such a manner that any person skilled in theart can make and use the inventions. The examples provide the best modescontemplated for carrying out the inventions, although it should beunderstood that various modifications can be accomplished within theparameters of the present inventions.

Examples of closure devices and of methods of making and using theclosure devices are described. Depending on what feature or features areincorporated in a given structure or a given method, benefits can beachieved in the structure or the method. For example, closure devicesusing a finger shield or guard may be easier and safer to use. Closuredevices having finger grasping surfaces with selected configurations mayalso help in holding and using the closure device. Closure deviceshaving visual indicator marks also make such closure devices easier andmore reliable to use. Moreover, closure devices having predeterminedsuture delivery configurations may also provide more reliable andconsistent bites of appropriate tissue layers desirable for suturingthese layers than conventional techniques.

Improvements are also provided to components with which the closuredevices may be used. For example, needles or other suture introducersmay make it easier to use the closure device where the needle hasimproved suture holding and release characteristics. They may also beeasier to use with needle insertion indicators or stops for reducing thepossibility of excessive needle insertion. Indicators on the needles mayalso be used with suture holding grooves in the needle tip to indicatethe relative orientation of the suture holding groove when such groovesare not directly visible to the operator.

These and other benefits will become more apparent with consideration ofthe description of the examples herein. However, it should be understoodthat not all of the benefits or features discussed with respect to aparticular example must be incorporated into a closure device, componentor method in order to achieve one or more benefits contemplated by theseexamples. Additionally, it should be understood that features of theexamples can be incorporated into a closure device, component or methodto achieve some measure of a given benefit even though the benefit maynot be optimal compared to other possible configurations. For example,one or more benefits may not be optimized for a given configuration inorder to achieve cost reductions, efficiencies or for other reasonsknown to the person settling on a particular product configuration ormethod.

Examples of a number of closure device configurations and of methods ofmaking and using the closure devices are described herein, and some haveparticular benefits in being used together. However, even though theseapparatus and methods are considered together at this point, there is norequirement that they be combined, used together, or that one componentor method be used with any other component or method, or combination.Additionally, it will be understood that a given component or methodcould be combined with other structures or methods not expresslydiscussed herein while still achieving desirable results. Closuredevices for trocar openings are used as examples of a closure devicethat can incorporate one or more of the features and derive some of thebenefits described herein, and in particular closure devices forabdominal tissue openings. Closure of trocar openings in abdominal wallspresent particular issues for acceptable results, and closure devicesfor abdominal openings will be considered in more detail. However,closure devices other than for abdominal wound closures can benefit fromone or more of the present inventions.

It should be understood that terminology used for orientation, such asfront, rear, side, left and right, upper and lower, and the like, areused herein merely for ease of understanding and reference, and are notused as exclusive terms for the structures being described andillustrated.

In accordance with one example of apparatus that can be used for closinga tissue opening, for example a trocar opening in the abdominal wall,and where the apparatus reflects one or more methods that can be usedfor tissue closure, a closure device and needle assembly 100 (FIGS. 1-5) includes a closure assembly or closure device 102 and a needleassembly 104. The closure device 102 can be used with the needleassembly 104 as discussed herein, or with other suture introducers orneedles, and the needle assembly 104 as discussed herein can be usedwith other closure devices. However, for purposes of some of theexamples, the closure device 102 and the needle assembly 104 will beconsidered as being used together. Additionally, the present discussionfor the application of the closure assembly will be in the context ofclosure of an abdominal opening, but it should be understood that othertissue closures can be carried out with one or more of the components ofthe assembly.

In the context of a trocar opening 106 (FIG. 2 ) in an abdominal wall108, the opening 106 extends through a skin and superficial layer 110that may include muscle, depending on the location in the abdomen atwhich the opening is made. The skin and superficial layer 110 will bereferred to as the skin layer 110 for simplicity. Underlying the skinlayer 110 is a fascial layer 112 having a thin peritoneum 114 (notseparately shown for simplicity). The peritoneum forms the lining of theabdominal cavity outside the internal organs (not shown), and it isthrough the skin layer 110, fascial layer 112 and peritoneum 114 thatthe trocar opening and trocar permit access for an operator to theinternal organs. Once the surgery is complete, the trocar opening isclosed by closing the fascial layer 112 and peritoneal layer 114, whiletaking care to avoid puncturing or injuring any underlying organs. Oneway to minimize puncturing underlying organs during the closure processis to retract the tissue layers away from the underlying organs and tolimit or carefully control the ingress of suture introducers orretrievers beyond the tissue wall (peritoneal layer), for example in themanner described more fully below.

The closure device 102 in the present example includes a closure body116 (FIGS. 1-5 ). The body extends from a proximal portion 118 to adistal portion 120. Generally, the proximal portion 118 is used tocontrol and manipulate the closure device, and the distal portion 120forms a working structure to be inserted under the peritoneal layer. Thedistal portion 120 in the present examples is used to present a targetat a known and predetermined location where a suture can be reliablyplaced or retrieved, for example even without visualization, and in sucha way that suture bites can be made at optimal locations for formingreliable closures. For example, the distal portion 120 can be used as atarget for inserting one or more sutures through the fascial layer 112and into the target, and in another example, the distal portion 120 canbe used as a target for inserting a retrieval tool through the fasciallayer 112 to the target for retrieving a pre-disposed suture portionfrom the target and withdrawing the suture through the fascial layer 112and a tissue opening 106 to help in closing the opening. The closuredevice 102 also includes an intermediate or middle portion 122, whichwill be generally considered that portion of the closure body 116residing within the opening 106 during normal use. The middle portion122 generally will extend between the outer surface of the skin layer110 and the peritoneal layer 114. The middle portion 122 includes atleast one element that helps to reliably and repeatably place a sutureintroducer or retriever at the predetermined target site without theoperator having to substantially adjust or vary the direction ofmovement of the introducer or the retriever. In the present examples, asdiscussed more fully below, the at least one element in the middleportion 122 that helps to reliably and repeatably place a sutureintroducer or retriever at the predetermined target site is a channel orpassageway, for example a trans lateral passageway, through the body 116of the closure device.

Considering the closure device 102 in more detail, the distal portion120 in the present example includes a plurality of suture-receivingelements 124. The elements 124 may be wings that form targets for asuture introducer such as the needle assembly 104. The wings 124 extendoutwardly in substantially opposite directions from the closure body 116in the deployed configuration shown in FIGS. 1-5 . They aresubstantially 180° apart and extend substantially perpendicular to acentral axis of the closure body. In other examples, the closure devicecould have a single wing or plural wings, whether arranged in pairs orotherwise. When arranged in pairs, they can be arranged in two, four,six or more pairs, as desired.

The wings 124 (see also FIGS. 24-28 ) are pivotally mounted torespective portions of a mounting structure 126 at the distal end of theclosure body 116. The wings 124 are mounted at opposite sides of agroove 128 (FIG. 15 ) centered on the central axis of the closure body,so that the wings can pivot simultaneously between the opened ordeployed configuration shown in FIGS. 1-5 and a closed or insertionconfiguration shown in FIG. 12 . The wings 124 are linked to andoperated through a pull rod 130 (FIGS. 1-3 ) through respective linkarms or expanders 132. Pull rod 130 extends upward into and issubstantially centered on the central axis of the closure body 116 forlongitudinal movement within the body. Upward movement of the pull rod130 pulls the link arms or expanders upward to move the wings 124 from acollapsed or insertion configuration shown in FIG. 12 to the expanded ordeployed configuration shown in FIGS. 1-5 . Downward movement of thepull rod 130 within the body 116 fold the link arms 132 down relative tothe body, thereby pulling the wings 124 downward to the closedconfiguration.

Suitable precision machining, injection molding, casting or other suchforming of the wings, link arms 132 and pull rod 130, and theirpositioning and mounting to or within the closure body 116 allowsaccurate positioning of the wings 124 when in the deployed configurationshown in FIGS. 1-5 . Therefore, when they are in the deployedconfiguration, the wing positions are accurately and reliably knownrelative to other points on the closure device. Likewise, the positionof any point on the wings 124 is also accurately and reliably knownrelative to any other point on the closure device. Therefore, withsuitable precision machining or forming of components on the closuredevice, the precise location of any point on a wing 124 is known and canbe used as a target for inserting or receiving a suture. Each wing 124includes a predetermined target location 134 (FIG. 1 ).

The target location can be used for reliably receiving a suture portion,for example through an introducer, or for reliably retrieving a sutureportion previously placed at the target location. In the presentexamples, each wing 124 includes a target element 136 securelypositioned in the target area 134 of the wing, and partly underneath atarget approach opening 138 formed in a top surface 140 of the wing. Inthe present examples where the introducers or retrievers approach thetarget opening at an angle, the target approach opening 138 is alsoformed with a central axis at an angle, substantially parallel orconforming to the angle of approach of the introducer or retriever. Thetarget approach opening 138 includes a wall 142 (FIG. 10 ) shown asextending substantially parallel to the central axis 142A of theopening. However, the walls can be conical or other selected shape orcross-sectional configuration. The walls are also shown as circularcylindrical, but they can have other configurations as well.

The size and shape of the target approach opening 138 can be determinedbased on a number of considerations. When used in conjunction with asuture introducer, these considerations may include the sutureintroducer diameter, the flexibility of the introducer, the travellength of the introducer from an exit port on the closure body 116 tothe opening 138, and the desired tolerance between the expected range ofmotion of the tip of the introducer and the minimum openingcross-sectional configuration.

The target element 136 in the present example is a structure havingsubstantially the same shape as a cavity 143 in the wing 124 and sizedsufficiently so that the target element is reliably retained in thecavity.

Alternatively, rather than being pre-cut to size and then assembled, thetarget element can be insert molded directly into the cavity 143 and canfill the opening 138. The target element 136 is formed from a materialsufficiently soft that the suture introducer can traverse and embed thesuture in the material. As shown in FIGS. 1-5 , the material also issufficiently soft so that the tip of the introducer can pass through thematerial. The target element is positioned so as to be substantiallycentered under the target approach opening 138.

The target element includes a proximally-facing surface 144 (FIG. 10 )with which the suture introducer comes into contact. In the presentexample, the surface 144 is initially unperforated, and lacks anyopenings, slits, slices or other breaks in the surface to ease thepenetration of the introducer past the surface. For situations wheremultiple closures are required in the same surgical setting and patient,the surface 144 can be used multiple times as long as the target element136 is able to maintain the embedded suture. The target element for thesurface and a substantial portion of the material below the surface issubstantially resiliently flexible. In one configuration, the targetelement is formed from a material that has a sufficiently highcoefficient of friction relative to the suture material so as tosuitably retain the embedded suture portion during normal operation. Forexample, it is desirable to ensure that the target element substantiallyretains the suture all the time while the wings are collapsed and theclosure device is being withdrawn from the trocar opening 106. Thesuture portion can then be cut from the closure device or more simplymanually pulled from the target element 136 material to allow anoperator to complete the closure of the trocar opening. In one example,the target element is formed from silicone rubber. Other materials (forexample biocompatible thermoset and thermoplastic materials) may be usedto suitably form the target having the desired characteristics.Additionally, the target material may consist of a single layer materialor may be of several layers, each layer having different characteristicsor properties designed to achieve the friction desired to hold thesuture in place but at the same time flexible enough to allow any needleor other suture carrying device to penetrate.

The pull rod 130 (FIGS. 1-11 ) controlling the positions of the wingscan take a number of configurations. In the present example, the pullrod is a substantially straight, longitudinally extending bar having arectangular cross-section extending from beyond the distal end of thebody through a similarly shaped channel in the middle portion and intothe proximal portion of the body. The pull rod is positioned on acentral axis of the body. The pull rod is substantially rigid so as toreliably transmit a force to enable movement of the wings 124 withminimal to no bending. The proximal end of the pull rod 130 is securedby a pin 146 to an actuator mechanism so that when the actuatormechanism is moved, the pull rod 130 and therefore the wings 124 arealso moved. The pin 146 is positioned to move axially within a pair ofoppositely formed slots 148 (FIGS. 11 and 16 and 20 ) in a side wall ofthe proximal portion of the closure body 116. The slots are formed so asto allow easy translation of the pin within the slots.

In the present example, the pin 146 is fixed to the pull rod and to anactuator sleeve 150 on the closure body 116. The sleeve 150 has asubstantially cylindrical body 152 (FIGS. 10-14 ) configured to slide upand down along an outer surface of the proximal portion of the body. Thepull rod 130 and the sleeve 150 are substantially axially fixed relativeto each other.

The sleeve 150 is an actuator device that an operator can use tomanipulate the wings 124. Manipulator elements such as finger rings 154on the sleeve 150 make it easier for an operator to move the actuatordevice up and down over the closure body 116. Other manipulator elementsmay be used, for example grip surfaces, curved trigger-shaped surfacesand the like. The finger rings 154 are oriented diametrically oppositeeach other on the sleeve body 152 for convenient manipulation by theoperator.

The actuator sleeve 150 may include a biased locking or latching elementhaving a cap or sleeve 156 (FIGS. 1-3, 5, and 12 ) secured on a boss orpost 158 (FIGS. 13-14 ) on an outside surface of the cylindrical body152. The locking element 156 in the present example is biased inward andis movable over the post 158 substantially radially relative to the body116, and includes a locking pin (not shown) fixed to the cap. Thelocking pin is insertable into and removable from one of two (in thepresent example) locking openings 160 and 162 (FIGS. 12 and 16 ).Locking opening 160 locks the sleeve 150 and therefore the wings 124 ina deployed configuration, and the locking opening 162 locks the wings124 in an insertion configuration such as is shown in FIG. 12 . Thespring bias in the locking pin keeps the lock in place until manuallyunlocked, and locks the sleeve 150 in place as soon as the pin isaligned with a given opening 160 or 162. Alternatively, the lock can bea set screw or other manual securement, an umbrella-style latchmechanism, living hinge or the like. The pin 146 in the pull rod and theslots 148 help to keep the sleeve 150 from pivoting about the body sothat the locking pin will no longer align with one of the openings 160or 162.

A top ring 164 (FIGS. 1-7 and 10-12 ) is fixed to the top of theproximal portion of the body 116. The top ring can be used as a thumbring by the operator and is oriented so as to extend substantiallyparallel to the finger rings 154 and substantially orthogonal to thewings 124 when deployed. The operator can use the top ring as areference or base as to which the actuator sleeve 150 is moved back andforth. A compression spring 166 (FIGS. 10-11 ) is positioned in a bore168 and biases the actuator sleeve 150 away from the top ring 164 by wayof contact between the spring 166 and the pin 146.

Therefore, the closure device is biased so that the wings are in theirinsertion configuration (FIG. 12 ) unless the sleeve 150 is fixed by thelocking pin in the opening 160, In the present example, the closuredevice includes an opening 170 (FIGS. 1, 9 and 17 ), which opens into apassageway 172. In the present examples, a second passageway 174includes a respective opening 176 (FIG. 17 ) substantially identical tobut diametrically opposite from the opening 170, Only the opening 170and the passageway 172 will be described in detail, and it will beunderstood that the second passageway 174 and second opening 176 aresubstantially identical to the first. Other openings and passageways maybe included to correspond to additional target elements other than theillustrated wings 124 such as are shown in FIG. 1 . The opening 170 isformed in the proximal portion of the closure body 116, and thepassageway 172 extends from the opening 170 at an angle, for exampletrans-laterally of the body 116. The passageway terminates at an exitopening 178 (FIGS. 3-4 ) formed in a side wall of the closure body 116in the middle portion 122 of the body. Generally, the passageway issubstantially straight and includes a center axis that passes throughsubstantially the center of the target access opening 138 in thecorresponding wing 124 (FIG. 1 ). The passageway can be configured inlength and cross-sectional dimension in conjunction with a sutureintroducer such as the needle assembly 104 so that the tip of the needleor suture introducer assembly 104 substantially always passes throughthe opening 138, even without visualization. Alternatively, thepassageway 172 can be slightly curved between the entry opening 170 andexit opening 178.

The opening 170 in the present example opens into a conical orfunnel-shaped lead-in or approach to the rest of the passageway 172. Theapproach makes it easier to introduce the needle assembly 104 to thepassageway. The remainder of the passageway to the exit opening 178 hasa substantially constant cross-sectional configuration and area untilreaching the external surface of the closure body 116. In the presentexamples, the passageway 172 is substantially circular in cross-sectionand in one example is sized to smoothly accommodate the needle shaft ofthe needle assembly 104 and two times the cross-section of a suture toaccount for a double backed portion of suture, without wear on thesuture or binding in the passageway.

As can be seen by comparing FIGS. 1-12 , the passageway 172 extends fromthe opening 170 on one side of the finger rings 154 to the wing 124 onthe opposite side of the finger rings. The passageway 172 does not crossthe rectangular bore in which the pull rod 130 travels. Additionally,respective passageways do not intersect, thereby ensuring that asubsequent needle passage does not interfere with or damage apreviously-positioned suture. The actual length of a passageway may beselected as a function of the vertical height or axial length over whichit is desired to have the suture pass through the tissue adjacent theexit opening 178 to the corresponding target area 134. The overalllength may also be selected as a function of the axial position of theopening 170. However, as described more fully below, it is desirable toestablish a relationship between the axial height from the exit opening178 to the top of the wing 124 and the lateral distance from the closurebody 116 to the center of the target opening 138.

When the closure device 102 is used to pass a suture through thesurrounding tissue and into a target area 134, it may include a sutureescape slot such as opening 180 extending from the entrance opening 170to the exit opening 178. The slot opening 180 is a substantiallystraight opening formed into the wall from the surface of the closurebody 116 to intersect the passageway 172 along with the entrance andexit openings 170 and 178, respectively. The slot opening 180 iscontained in a plane that also contains the central axis of thepassageway 172, Consequently, a suture passing through the passageway172 can be relatively easily manually extricated from the passageway bythe operator by shifting the suture outwardly through the slot opening180 facilitating a more rapid procedure. The width of the slot openingmay be slightly greater than the maximum cross-sectional dimension ofthe suture. However, the largest gap spacing of the slot opening is lessthan the smallest cross-sectional dimension of the needle or otherintroducer element extending along the passageway, so that the sutureintroducer does not move laterally significantly as it traverses thepassageway. Other configurations can omit a suture escape slot. Theclosure body 116 includes one or more surfaces such as gripping surfaces182. The gripping surfaces are positioned on a proximal portion of theclosure body, and in the present examples below the actuator sleeve 150.The gripping surfaces may be finger grasping or gripping surfaces distalof the openings 170 and 176 but still proximal of the middle portion 122of the closure body. The gripping surfaces may include surfaceconfigurations complementary to finger curvature, and they may includesurface variations or textures for helping the operator to reliablygrasp the body of the closure device. In the illustrated example, thesurface variations include transversely extending ridges 184 (FIGS. 7and 11 ). In other configurations, the surface variations may includegrooves, knurling, dimples, surface texture variations or otherconfigurations to help the operator reliably grasp the body of theclosure device. In the illustrated example, the gripping surfaceincludes curved surfaces as well as surface variations. Additionally,the gripping surfaces include oppositely facing, orthogonal finger gripson the body.

The illustrated example includes, though closure devices can omit one orthe other or both, a finger shield or guard 186 around the openings 170and 176 for the passageways and proximal of the grasping areas. Theshield or guard 186 helps to protect the operator's fingers or hand fromaccidental needle stick as a needle is introduced into one or the otherof the openings. In the illustrated example, the guard or shield ispartly distal of the openings but still proximal of the middle portion122 of the body. This allows the operator's finger or fingers to beplaced distal of the guard while still above the surface of the skin,and while a suture is being introduced to an opening in the closuredevice. In the present example, the guard or shield has a flat proximalsurface 188 and an elliptical perimeter. The guard or shield issubstantially planar and is thick enough to withstand impact and bendingduring normal use.

In the illustrated example, the openings 170 and 176 are formed in theproximal surface 188 of the guard or shield 186, on substantiallydiametrically opposite sides of the center axis of the body. The slots180 also extend through the guard or shield and outward to the perimeterthereof. In the present example, the grasping surfaces 182 are orientedto extend in a direction substantially parallel to the major axis of theelliptical guard or shield, Other configurations and relative dimensionsof the gripping surfaces and the guard or shield may also be used.

A substantial portion of the proximal area of the closure body 116 issubstantially cylindrical, for example to permit the actuator sleeve 115to slide along the body surface. Other configurations for the outersurface adjacent the actuator sleeve may also be used while stillpermitting the actuator sleeve to open and close the wings 124. Thefinger grasping surfaces are noncircular and non-cylindrical to makeeasier the grasping and manipulating the closure device. The remainderof the body of the closure device is substantially cylindrical in theperimeter surface, for example to easily accommodate the shape of thetrocar opening. The middle portion 122 of the closure body 116 has asubstantially straight cylindrical sidewall, except for the slots 180and the exit openings, and it extends to a first taper surface 190. Thetaper surface 190 extends distally to a reduced diameter body surface192 between the taper 190 and the mounting structure 126 for the wings.The taper surface 190 is configured and placed axially on the closurebody to permit a portion of the fascial layer 112 ingress against theclosure body and further underneath the path of the suture-carryingneedle.

The closure body 116 in the present example includes at least oneindicator or marker for indicating a location of the closure bodyrelative to surrounding tissue. In the illustrated example, a proximalindicator 194 is formed in at least part of the body surface and extendsat least partly around a perimeter of the body at a given axial positionon the body. The proximal indicator 194 can be used to provide theoperator with an indication of the maximum depth to which the operatorshould insert the device into the trocar hole relative to the skin layerprior to commencing the closure procedure with the closure device. Theproximal indicator in the present example is the most proximal indicatorof a plurality of indicators. The proximal indicator helps to reduce thepossibility that the closure device or needle or suture introducercomponent is introduced too great a distance beyond the abdominal wall.The axial position of the proximal indicator away from the closed wings124 is selected as a function of typical tissue thickness for openingsfor which the closure devices to be used. Once the maximum tissue depthis reached, visualization or other indicators can be used to confirm ifdesired that it is appropriate to deploy the wings 124. A proximalindicator can also be used for other purposes.

In the present examples, an intermediate indicator 196 is positionedcircumferentially around the closure body 116 in the middle portion 122.The intermediate indicator 196 is positioned slightly below the exitopenings, and otherwise substantially encircles the body. Theintermediate indicator at the position below the exit openings can beused to note the location of the exit openings for example relative tothe fascial layer 112. For example, as can be seen in FIG. 2 , theintermediate indicator 196 occurs below the exit openings but above thestart of the fascial layer 112. Consequently, introduction of a suturethrough the fascial layer will have the suture pass through the fullthickness of the fascial layer, for example as illustrated in FIG. 2 .It is desirable to have the indicator 196 slightly below the exitopenings so that the operator can confirm that a suture introducedthrough the closure device will transit the entire thickness of thefascial layer. This indicator 196 also acts as visual warning to theoperator that the patient's soft tissue bed may be too insubstantial interms of thickness and, if the indicator is at or near the skin layerupper surface, that the needle will exit at a point above the skin levelinstead of below it as desired, A distal marker or other indicator canbe used to indicate a desired position for the closure device within thetrocar opening relative to the peritoneal layer to begin or transitionthe closure device from an insertion configuration to a deployed or openconfiguration. For example, indicator 198, when visible beyond theperitoneal layer, indicates that the wings 124 have sufficiently clearedthe peritoneal layer and can be opened to safely deploy the wings in thetypically insufflated abdominal cavity. The wings can then be deployedby pulling up on the finger rings 154, thereby sliding the actuatorsleeve 150 proximally to pull up on the pull rod 130.

In a further example, a distal marker 200 (FIG. 16 ) may be positionedon the body proximal of the body distal end and of the wings 124. Thedistal marker 200 can be used when the closure device is preloaded withone or more sutures before insertion into the trocar opening. When thewings 124 are preloaded and deployed, and the peritoneal layer isproximal of the distal indicator 200, there is sufficient clearancebetween the peritoneal layer and the target area 134 on the wings for aretriever such as one with jaws or a clasp to actuate, secure a sutureportion, and withdraw the suture portion through the fascial layer andoutside the skin layer. Other markers or indicators can also be used asdesired. One or more of the indicators may be formed by grooves or othersurface discontinuities visible or that can otherwise be sensed on theclosure body. The indicators can be painted, pad printed, texturized, ormay include some other detectable material or indicator for sensing theposition of the indicator relative to the surrounding tissue.

In the example shown in FIG. 2 , the proximal indicator 194 and thedistal indicator 198 are formed on the closure body 116 to indicate themaximum tissue depth for insertion of the closure device. The spacingbetween the two indicators is determined by the maximum expected tissuedepth for a large population of expected patients, and the twoindicators formed accordingly. Other populations such as morbidly obeseor exceptionally thin patients may lead to adjustments on the locationsof these indicators. The intermediate indicator 198 is positionedaxially on the external surface of the closure body slightly below theexit openings for the passageways 172 and 174. The exit openings in turnare positioned on the closure body an axial distance above the deployedlevel of the wings 124 sufficient to permit traversal by thesuture-carrying needle of the entire thickness of the fascial layer 112.

One or more of the indicators can therefore be used for visual or otherforms of confirmation for the operator that the positioning of theclosure device will achieve the desired suture placement and closureconfiguration. Similarly, with the closure device having the spacingconfiguration such that the exit openings are a predetermined distancefrom the upper level of the deployed wings, and such that the targetareas 134 on the wings are spaced a predetermined distance from theadjacent body surface, the operator knows that proper positioning of theclosure device will produce the desired suture bite in the fasciallayer. Therefore, with the intermediate indicator 196 located slightlybelow the exit openings, and the distal marker 198 located at the levelof the upper wing surfaces, any visual inspection that reveals theperitoneal layer resting on the wings 124 and the intermediate locator196 above the fascial layer, gives the operator secondary confirmationthat the desired suture bite in the fascial layer results.

In one configuration of a closure device 102, such as where the deviceis used as a target for sutures introduced after the closure device isfully deployed with the wings 124 under the peritoneal layer 114, theclosure device 102 can be given a design to achieve a desired suturebite of the fascial layer. For the average patient population, a desiredsuture bite is one where the suture traverses the peritoneal layer 114(FIG. 2 ) about 1 cm from the edge of the trocar opening 106. Therefore,the center of the target access opening 138 in the top of the wing 124can be positioned a distance 202 of 1 cm measured perpendicular to theadjacent surface of the closure body. Therefore, when the closure device102 is positioned in the trocar opening as depicted in FIG. 2 , thefascial layer 112 closes around the distal portion, including the taper190 of the closure body. The target access opening 138 is thenpositioned at the peritoneal layer 1 cm from the adjacent edge of thetrocar opening. Likewise, visual inspection will reveal that the distalindicator 198, which is 1 cm away from the target access opening 138, isproperly positioned relative to the peritoneal layer, and subsequentinsertion of sutures will produce the desired suture bite for thefascial layer.

Likewise in the configuration of the closure device described in theimmediately preceding paragraph, for average patient populations, havingthe exit openings 178 for the suture carriers sufficiently spaced fromthe tops of the deployed wings 124 will ensure that the sutures willtraverse the entire thickness of the fascial layer 112. Therefore, asdepicted in FIG. 2 , the exit openings 178 of the passageways for thesuture carriers are placed a distance 204 axially above the tops of thedeployed wings 124 equal to about 2.5 cm. Similarly as depicted in FIG.2 , the suture-carrying needle of the assembly 104 enters the fasciallayer 112 well away from the trocar opening wall and traverses theentire thickness of the fascial layer. Likewise, where the fascial layercloses around the tapered portion 190 and the distal portion of theclosure body above the wings 124, the suture exits the peritoneal layerabout 1 cm outward of the trocar opening wall. Therefore, the distances202 and 204 can be considered to form a right triangle where the twoperpendicular sides have a ratio of 2.5:1. A closure device where thetarget access opening 138 is 1 cm away from the adjacent body wall andthe exit openings are 2 cm above the deployed wings will produce themost desired or optimal suture bite. Therefore, one desired ratiobetween the perpendicular sides of the triangle is approximately 2.5:1where the target access opening is on the wing 124 1 cm away from thebody. Where the distance 202 is 1 cm, the ratio can be less than 2.5:1but it is still desirable that the suture traverse the entire thicknessof the fascial layer 112. This result is achievable by configuring theclosure device with these dimensions and suitable tolerances in thepassageways and by configuring the needle assembly 104 so that theneedle shaft and its tip as a result do not bend significantly out ofthe linear path from the exit to the target defined by the passageway174. The target access opening in other examples can be as little as 0.5cm and may be as much as 2.0 cm away from the body (measureperpendicularly). Also in other examples, the exit openings can be asclose as 1.0 cm above the top of the wings or space as much 4.0 cm away.While the closure device can be designed with other configurations toproduce different suture bites, it is believed that the closure devicesdescribed can reliably and repeatably produce the desired suture biteand closure configuration. Additionally, while visualization of theindicators or markers is useful for confirming proper positioning,precise manufacture of the closure device and the needle assembly orother introducer assembly can reliably and consistently produce theintended result in the tissue beds likely to be encountered in aclinical setting, A suture introducer can be used with the closerdevices discussed herein as well as with other tissue closure devices.One example of a suture introducer includes the needle assembly 104(FIGS. 29-31 ). The needle assembly 104 includes a proximal handleportion 300 and a distal needle portion 302. The handle 300 includes adisc-shaped cap 304 having a substantially flat end face and an outerdiameter approximately the same as the maximum outer diameter of therest of the handle. In the present example, the handle 300 includes apair of oppositely-disposed finger grasping surfaces 306, shaped tooptimally conform to curved finger surfaces. The grasping surfaces ortextures may include surface variations 308 to help in reliably grippingthe handle and manipulating the needle assembly. In this example, thegrasping surfaces 306 are positioned immediately distal of the cap 304.

The handle may also include relatively shallow concave surfaces 310extending on opposite sides of the handle over a substantial length ofthe handle, and on the same sides as the grasping surfaces 306, Thesurfaces 310 also help the operator to properly hold and manipulate theneedle assembly in a closure procedure.

The needle 302 includes a needle shaft 312 extending over a substantiallength of the needle. The needle terminates at a needle tip 314, havinga strength and configuration suitable for maintaining the point andstrong enough to penetrate the resilient material of the target element136. The needle 302 extends from the base 316 of the handle over apredetermined length to the tip 314. The base 316 is sized or otherwiseconfigured to contact the shield or guard 186 so that further ingress ofthe needle is prevented. Therefore, the predetermined length of theneedle 302 is selected such that, when the base 316 of the handlecontact the guard 186 of the closure assembly, the needle tip 314extends no more than a predetermined distance beyond the target element136. In one example, the predetermined distance beyond the targetelement 136 may be less than or approximately the same as the distancethat the pull rod 130 extends below the bottom surfaces of the deployedwings 124. Pre-selecting the amount of exposed needle tip extendingbeyond the wings 124 helps to reduce the possibility of unintendedneedle stick, for example of internal organs within the insufflatedabdominal cavity. The handle or other parts of the needle assembly can,in addition or instead, have other surfaces for contacting the closuredevice to limit further ingress of the needle assembly.

The needle includes a distal end portion 318 having a suture retainingor carrying portion in the form of a groove 320. The groove is formed inone side surface of the needle shaft 312 starting at an axial positionadjacent where the needle point 314 transitions to the full needle shaftdiameter. The groove includes an entrance portion 322 formed in part bya proximally-extending ramp surface 324 and a protrusion 326. The largerspacing between the ramp surface 324 and the protrusion 326 is aboutseveral times the diameter of the suture to be used with the needle 302.The smallest spacing between the protrusion 326 and the ramp portion 324is approximately the diameter of the suture.

The protrusion 326 extends distally from the needle shaft 312 and it isspaced apart from a long side 330 of the groove. The protrusionconverges on the open side and on the groove side to a rounded tip 332to minimize any damage to the suture when the suture contacts theprotrusion. The minimum spacing for the groove between the long side 330and the protrusion side 334 is slightly less than a diameter of thesuture to be used with the needle, for example a size 0 suture. Theminimum spacing for the groove is selected so that the suture,represented schematically at 336, requires a proximally-directed forceto pull the suture past the restriction in the groove, at which pointthe suture would be depicted in FIG. 31 as squeezed or elongated in thedirection of less constriction until the suture is past the restriction.The protrusion 326 can be formed as a rigid section or as a flexiblesection such that it can be deflected during suture loading or duringthe release of the suture. For example, the operator or a machine cangrasp the suture on opposite sides of the groove and pull the sutureinto the groove 320 in the proximal direction along the ramp 324 andagainst the resistive force created by the restrictive spacing betweenthe walls 330 and 334. The restrictive spacing is preferably such as tokeep the suture from falling out of the groove by force of gravity ifthe needle and suture are pointed downward with the suture hanging fromthe groove 320. The restrictive spacing is selected so that a greaterforce is required to remove the suture from the groove, and the greaterforce is on the order of the frictional force developed between a sutureportion and the material of the target element 136, such as siliconerubber, when a suture portion is embedded in the target material. Therestrictive spacing of the groove can be formed by cutting or otherwiseforming the groove to have a dimension smaller than the outer dimensionof the suture, biasing the protrusion 332 toward the groove wall 330 orin other ways.

The needle assembly also includes an indicator 338, in the presentexample on the handle, for indicating the relative orientation of thegroove 320 to ease loading of suture especially in dark operating roomsas the groove feature is discrete and could be difficult to see clearly.The indicator can also be used to determine the orientation of thegroove and the suture therein when the needle assembly and suture havebeen introduced into a passageway in the closure device or further intothe tissue or target. In the illustrated example, the indicator 338 is alongitudinally extending ridge formed on the handle and extendingsubstantially the full length of the handle. A gap may be formed betweensections of the ridge. The indicator 338 may be positioned during use sothat the groove 320 and the supported suture in the target element 136face away from the body 116 of the closure device. One or more of thepresently-described apparatus can be used for closing tissue openingsusing methods described herein, and other apparatus can be used with oneor more of these methods as well. In one process, a tissue opening forexample one formed by a trocar can be closed by removing the trocar andintroducing a closure device into the opening. In a first example, theclosure device is not preloaded with any sutures, and in a secondexample the closure device is preloaded with one or more sutures.

In the first example, a closure device such as that of 102 illustratedin FIGS. 1-12 is placed in the insertion configuration, shown in FIG. 12. The actuator sleeve is placed at a distal position (FIG. 12 ) and thelocking pin of the lock 156 inserted into the distal opening 162 on theclosure body (FIG. 16 ). The wings 124 extend axially of the body andhave their respective flat faces facing each other. The closure device102 is then inserted into the trocar opening 106 until the upper skinlayer approaches the proximal indicator 194. If the opening is undervisualization, the closure device can be inserted until the distalindicator 198 passes beyond the peritoneal layer 114. Once it is decidedthat the closure device is inserted sufficiently for deployment of thewings 124, the locking element 156 is withdrawn from the second opening162 and the actuator sleeve moved proximally until the locking pin canbe engaged with the proximal opening 160. As the actuator sleevetranslates proximally, the pull rod 130 translates axially in theproximal direction within its rectangular shaft in the body. The pullrod 130 pulls the link arms 132 upward causing wings 124 to pivot aboutretaining pins through the mounting structure 126 at the distal end ofthe body. When the locking element 156 engages the proximal opening 160the wings 124 are fully deployed substantially laterally andperpendicular to the central axis of the body and to the pull rod 130.The upper surfaces 140 of the wings are substantially adjacent theperitoneal layer and the target access openings 138 are aligned withtheir respective passageways in the body 116.

The needle assembly 104 has been previously loaded with an adequatelength of suture 336 by placing a bight of an end portion of the sutureon the shaft 312 proximal of the protrusion 332 (FIG. 31 ). While thesuture contacts the side of the needle, the suture is moved distallyalong the converging surface toward the tip 332 and down into theopening 320. The suture 336 is then moved proximally along the rampsurface 324 and under the protrusion 326 and moved against the grooverestriction by application of an increased force until the suture 336seats in the bottom of the groove. The holding of the suture can betested by releasing the suture and letting it hang from the groove. Thesuture-carrying needle can then be introduced into the opening 170 inthe closure device as represented in FIGS. 1-5 . The operator grasps theclosure device at the grasping surfaces 182 and lifts the closure deviceagainst the peritoneal layer and separates the tissue layers furtheraway from the underlying organs or other tissues in the abdominalinsufflated cavity. With the operator's fingers underneath the shield orguard 186, the needle assembly is inserted into the opening 170 andadvanced along the passageway 172 with the needle indicator 338 on thehandle oriented as shown in FIGS. 1-5 . As the needle tip exits the exitopening 178, the needle tip penetrates the tissue surrounding the trocaropening in the area above the fascial layer 112. As the needle shaftcontinues along the passageway and the needle tip penetrates furtherinto the tissue, the needle tip approaches the target access opening138, all the while carrying the loaded suture end portion.

The needle point punctures the proximal facing surface of the targetelement 136 and continues through the target element until the base 316of the needle handle bottoms out against the guard 186 or the conicalopening 170, as predetermined by the relative sizes and positions of theguard and the handle. If operating under scope-based visualization,suitable embedding of the suture in the target element can be confirmed.The needle assembly can then be withdrawn from the target element, withthe frictional engagement between the silicone rubber of the targetelement and the suture acting to hold the suture embedded in the targetelement as the needle is withdrawn. The needle assembly is fullywithdrawn from the closure device and reloaded with the other end of thesuture or another suture (or another needle assembly can be used). Whilethe operator grasps the closure device about the grasping surfaces 182and lifts the device, the suture-loaded needle assembly 104 isintroduced to the second opening 176 and along the second passageway 174to embed the suture in the target element of the diametrically oppositewing 124 (see phantom needle in FIG. 2 ). The needle assembly is thenwithdrawn again. With closure devices having more wings and passageways,the process (procedural steps described above) can be repeated for eachone. The locking element 156 is then released and the spring bias movesthe actuating sleeve distally, closing the wings 124 until the lockingbutton 156 engages the second opening 162 and locks in place. Theclosure device holding the embedded suture ends in each wing can then beremoved from the trocar opening, also drawing suture into the tissue andout through the trocar opening. The suture lengths residing in thepassageways can be removed out of the slots 180 either before or afterthe closure device is removed from the trocar opening. The embeddedsutures can also be manually removed from the silicone rubber targetelements in the wings. The sutures can then be tied off as desired tocomplete the closure.

In the second example process, one or more sutures are first anchored onrespective wings of a closure device and then subsequently introducedinto a tissue opening, for example a trocar opening. With a pair ofwings, a single length of suture can have its ends anchored inrespective wings with the connecting loop remaining outside the trocaropening. The suture ends can be anchored on the wings for example bybeing embedded in a relatively high friction material such as siliconerubber, or by engaging one or more structures on or about the wings suchas by interference fit or frictional engagement, by wrapping, by a cleatarrangement, by a miniaturized clamp or by various other active orpassive means. In one configuration, a suture end portion is anchored byspaced apart anchor elements on each side of the wing and with theintermediate suture length extending over an open area forming thetarget area for a grasping or retrieving element. The grasping orretrieving element will then approach the target area, for example withjaws or other grasping mechanisms open to engage the suspended sutureportion. The sutures can be left outside the body of the closure device.

The closure device with the sutures mounted and in the insertionconfiguration is then inserted into the trocar opening until theindicators show that the closure device is sufficiently inserted. Thewings are then deployed, and the closure device positioned within thetrocar opening to form a gap between the wings and the peritoneal layer.While the operator grasps the closure device at the grasping surfaces182, a retrieval tool is introduced into the opening 170 and along thepassageway 172. The retrieval tool is sufficiently sharp to pierce thetissue layers in order to reach the embedded suture on the associatedwing. The retrieval tool may include jaws or other grasping elements forsecurely holding the suture. Alternatively, the retrieval tool canutilize a groove which enables the operator to let the suture ‘run’instead of being grasped when withdrawn as commonly done in orthopedicapplications involving sutures. This method would include loading themidsection of the suture, providing an adequate length of suture on therespective anchor elements before insertion of the device. In eitherembodiment, as the working portion of the retrieval tool exits theperitoneal layer, the working portion is activated, for example byopening jaws, and the tool is advanced to retrieve the midsection of thesuture mounted in the anchor element. Once the tool is fully advanced inthe passageway, such as up to a stop point, the jaws or other workingportion are closed and the suture is either allowed to run or is graspedand withdrawn until it exits the tissue layers and the passageway, andthen released once a suture end is visible. The retrieval tool is theninserted into the other passageway to retrieve the other suture elementin like manner. These procedural steps can be repeated if multiple wingsare used. It is also noted that other mechanical means can be used toretrieve the suture.

When each of the suture end portions have been retrieved and released,the closure device can be reset to the insertion configuration andremoved from the trocar opening. Because the sutures are free of theclosure device, suture escape slots are neither used nor necessary toremove suture elements from the passageways. Traction draws the freeends of the suture tight with the intermediate loop portion against theopening and the suture ends are then tied off to effect a full thicknessclosure of the fascial layer.

With a closure device where the suture is anchored on the wings beforethe closure device is inserted into the trocar opening, the closuredevice may be configured to have a longer body to provide the gapbetween the peritoneal layer and the target wings, to therebyaccommodate the working portions of the retrieval tool. In thisconfiguration, the distal marker 198 is moved proximally to the distalend of the taper 190, The length of the body, for example the taper, isincreased a like amount so that the distal indicator 198 stillsubstantially aligns with the peritoneal layer. Additionally, becausethe trajectory of the retrieval tool is still determined by the centralaxis of the passageway 172, which has now shifted axially upward awayfrom the target wings, the target access opening or the target area forthe retrieval tool is shifted radially outward from the closure bodybeyond 1 cm (assuming the angle of inclination of the passageway isunchanged). The actual increase in the distance 202 (FIG. 2 ) can becalculated as a function of the increase in body length of the closuredevice.

The closure device can be formed from a number of bio-compatiblematerials, such as polycarbonate, and the various metal parts may beformed from suitable medical grade materials including stainless steel.The needle handle may also be formed, machined, cast or molded from asuitable biocompatible material. The needle shaft and tip may be formedfrom a hardened stainless steel or similar material. In some examples,though other dimensions may be used as well, a standard length closuredevice would have an outside diameter of approximately 12 mm and a 2.5inch working length, with the passageway exit holes about 0.5 cm abovethe peritoneum and with the wings producing a lateral bite of about 1cm. An extra-length device for example may have a 3.5″ working lengthand the exit holes would be about 3 cm from the peritoneum and with thewings provide a lateral bite of about 1 cm. The needle on the needleassembly may have an approximately 10 cm minimum working length with amaximum 2 mm outside diameter.

Having thus described several exemplary implementations, it will beapparent that various alterations and modifications can be made withoutdeparting from the concepts discussed herein, Such alterations andmodifications, though not expressly described above, are nonethelessintended and implied to be within the spirit and scope of theinventions. Accordingly, the foregoing description is intended to beillustrative only.

The invention claimed is:
 1. A tissue closure device comprising: alongitudinal body having a proximal portion for manual actuation of thedevice and a distal portion for insertion into an opening in a tissuelayer, the distal portion having an outer surface; and a first sutureholding element and a second suture holding element, each supported bythe distal portion, wherein the longitudinal body defines a firstpassageway between a first proximal opening defined on the proximalportion and a first distal opening defined on the outer surface, and thefirst passageway is aligned with the first suture holding element whenthe first suture holding element is in a deployed position, wherein thefirst passageway extends at an angle to a central axis of thelongitudinal body between the first proximal opening and the firstdistal opening, wherein the longitudinal body defines a secondpassageway between a second proximal opening defined on the proximalportion and a second distal opening defined on the outer surface, andwherein the second passageway extends at an angle to the central axis ofthe longitudinal body between the second proximal opening and the seconddistal opening, and the second passageway is aligned with the secondsuture holding element when the second suture holding element is in adeployed position.
 2. The tissue closure device of claim 1, furthercomprising a proximal facing surface defining a guard or shield.
 3. Thetissue closure device of claim 2, wherein the proximal facing surface ofthe guard or shield is substantially planar.
 4. The tissue closuredevice of claim 2, wherein the proximal facing surface extends laterallyof the outer surface.
 5. The tissue closure device of claim 2, whereinthe proximal facing surface is flat.
 6. The tissue closure device ofclaim 2, wherein the proximal facing surface has an ellipticalperimeter.
 7. The tissue closure device of claim 2, wherein the proximalportion has a taper distal of the proximal facing surface.
 8. The tissueclosure device of claim 2, wherein the proximal portion has a graspingsurface positioned distal of the proximal facing surface.
 9. The tissueclosure device of claim 8, wherein the proximal portion has a pair ofgrasping surfaces on opposing sides of the longitudinal body.
 10. Thetissue closure device of claim 8, wherein the grasping surface includesgrooves, knurling, dimples, and/or surface variations or textures. 11.The tissue closure device of claim 1, further comprising a pull rodextending through the longitudinal body and configured to deploy thefirst suture holding element and the second suture holding element. 12.The tissue closure device of claim 11, further comprising an actuatorconnected to the pull rod.
 13. The tissue closure device of claim 1,wherein the first proximal opening and the second proximal opening eachhas a conical or funnel-shaped lead-in.
 14. The tissue closure device ofclaim 1, wherein each of the first suture holding element and secondsuture holding element is configured to pivot laterally away from thecentral axis of the longitudinal body to the deployed position.